5. data and comments. 5, page-70

re:5. 5
http://stocknessmonster.com/news-item?T=NNL6vgCgQgrcxEkRg7ZqkD&E=ASX&S=EPT&N=217704

Extract:
Company Announcement European clinical trials for PMLE to be expanded For more information contact: Iain Kirkwood, Chief Administrative Officer, EpiTan Limited, Tel: 03 9662 4688 Richard Allen, Monsoon Communications, Tel: 03 9620 3333

[email protected] www.epitan.com.au Melbourne, Australia EpiTan Limited [ASX:EPT] today announced that, following a comprehensive review of its clinical trial strategy in Europe, it will be substantially expanding its clinical trials for polymorphous light eruption (PMLE) - otherwise known as sun poisoning - during 2004.

The company will now lodge a Clinical Trial Exemption (CTX) application with the European Medicines Evaluation Agency (EMEA) to expand the number of PMLE trial sites in Europe to include Great Britain and Sweden.

Twenty-one percent of Swedes suffer from PMLE, one of the highest rates in the world.

The company’s current German PMLE proof-of-concept study will be deferred, despite receiving ethics committee approval, to facilitate this expansion and to allow the use of the new lower dosage sustained release solid injectable, which will be used in place of the larger implant.

The company announced in February this year that, as a result of better than expected efficacy in its Queensland implant dose escalation trial, a much smaller sustained release solid injectable containing significantly less drug is now being produced.

In the Queensland trial the first six volunteers, who received the two lowest levels of the melanin-producing drug Melanotan®, quickly demonstrated substantial increases in melanin levels.

After 60 days the volunteers still had a profound natural tan.

The CTX application is expected to be lodged in mid 2004 and trials should begin in the European winter. Dr Wayne Millen, EpiTan’s Managing Director said, “We are confident that elevating melanin levels with Melanotan will help those affected by PMLE.

After a thorough review of our European clinical trial strategy we concluded it would be more pragmatic to standardise all future studies and trials around the new sustained release solid dose injectable.

This is going to be the formulation with which we expect Melanotan to be commercialised first so we didn’t want to waste any time with formulations which have been superseded.
END